Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices

Socal Heart16 enrolled

Overview

This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.

Magnetic resonance imaging (MRI) is a critical diagnostic tool known for its non-invasive nature and high-resolution imaging capabilities. However, its safety in patients with cardiac implantable electronic devices (CIEDs), particularly those with mixed-lead systems, remains a significant clinical concern. This report investigates the safety and efficacy of MRI in such patients, where generators and leads originate from different manufacturers and are not officially deemed MRI-conditional.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Safety of MRI

Interventions

MRIDIAGNOSTIC_TEST

Magnetic resonance imaging (MRI) is a vital diagnostic tool in modern medicine due to its ability to produce detailed images of the body's internal structures without using ionizing radiation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * have a mixed-lead CIED * clinical relevant MRI Exclusion Criteria: * same manufactured CIED

Locations (1)

Southern California Heart Specialists

Pasadena, California, United States

Outcomes

Primary Outcomes

Evaluation of Changes in Device Battery Voltage (Volts)

report Device Battery Voltage (in Volts) prior to the MRI and after the MRI and determine if there was a change in voltage greater than 10% from the initial measurement to the final measurement.

Time frame: Immediately Prior to MRI and Immediately after MRI

Evaluation of Changes in Lead Impedance (Ohms)

report lead impedance (in Ohms) prior to the MRI and after the MRI and determine if there is a change in impedence greater than 20% from the initial measurement to the final measurement.

Time frame: Immediately Prior to MRI and Immediately after MRI

Evaluation of Changes in Lead Threshold (Voltage) Before and After MRI

report lead threshold in (voltage) prior to MRI and after the MRI and determine if there is a change greater than10% from the initial measurement to the final measurement.

Time frame: Immediately Prior to MRI and Immediately after MRI

Secondary Outcomes

Evaluation of Changes in Patient Clinical Outcomes (Rhythm, Symptoms, Cardiac Arrest, or Death) Before and After MRI

We will review medical records and determine if there were any observed change in patient rhythm, symptoms (such as chest pain, syncope), cardiac arrest or death after the MRI was completed.

Time frame: Immediately Prior to MRI and Immediately after MRI

Data from ClinicalTrials.gov

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